Start-Up Associate II

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit. In this roleyour key tasks will include:
* Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
* Ensure planned dates are reliable and up to date in CTMS departments/study teams
* File documents in the (e)TMF for which they are the document owner
* Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner
* Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
* Provide relevant documents in compliance with local regulation
* Support review of technical, pre-clinical and clinical reports for regulatory submissions
* Interact with regulatory authorities
* Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
* Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
* Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
* Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
* Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
* Interact with IEC/IRB
* Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
* Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
* Assist in adapting country SIS/ISF to site-specific requirements
* Provide country specific requirements to GSCM impacting site contracts’ process
* Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
* Negotiate within client approved contract and budget templates and negotiation parameters
* Communicate with sites and internal personnel regarding the status of contracts and contract related documents
* Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable
* Provide the final/draft CTA and site budget for submission, where required
* Obtain site signature as well as Sponsor/Allucent signature, as applicable
* Keep up to date with applicable local regulations impacting clinical trial contracts
* Assist in preparing the site-specific Essential Document Package and sending to sites
* Responsible for collection and first review of Essential Documents
* Provide the Global Essential Document Reviewer with the collected documents for independent review
* Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution
* Obtain authorization for the shipment of Investigational Product to the site
* Track relevant information and data in CTMS and/or other tracking tools To be successful you will possess:
* Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
* More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
* A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
* A thorough understanding of the drug development process
* Good oral and written communications skills
- fluent in Italian and English.
* Attention to detail.
* Able to perform well as a team member. Benefits of working at Allucent include:
* Comprehensive benefits package per location
* Competitive salaries per location
* Departmental Study/Training Budget for furthering professional development
* Flexible

Working hours
(within reason)
* Participation in our enriching Buddy Program as a new or existing employee
* Internal growth opportunities and career progression
* Financially rewarding internal employee referral program
* Eligibility for our Spot Bonus Award Program in recogni